메뉴 건너뛰기




Volumn 20, Issue 10, 2011, Pages 1014-1020

Pitfalls in meta-analyses on adverse events reported from clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

CREATINE KINASE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

EID: 80053274373     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2208     Document Type: Note
Times cited : (21)

References (33)
  • 1
    • 80053258013 scopus 로고    scopus 로고
    • Recovery.gov. Accessed March, 03
    • Recovery.gov. Accessed March, 03, 2010.
    • (2010)
  • 2
    • 77949651908 scopus 로고    scopus 로고
    • AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program
    • Chou R, Aronson N, Atkins D, et al. AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program. J Clin Epidemiol 2010; 63(5): 502-512.
    • (2010) J Clin Epidemiol , vol.63 , Issue.5 , pp. 502-512
    • Chou, R.1    Aronson, N.2    Atkins, D.3
  • 3
    • 20544439606 scopus 로고    scopus 로고
    • Challenges in systematic reviews that assess treatment harms
    • Jun 21
    • Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Inter Med Jun 21 2005; 142(12 Pt 2): 1090-1099.
    • (2005) Ann Inter Med , vol.142 , Issue.12 PART 2 , pp. 1090-1099
    • Chou, R.1    Helfand, M.2
  • 4
    • 0033610734 scopus 로고    scopus 로고
    • Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses
    • Nov 27
    • Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet Nov 27 1999; 354(9193): 1896-1900.
    • (1999) Lancet , vol.354 , pp. 1896-1900
    • Moher, D.1    Cook, D.J.2    Eastwood, S.3    Olkin, I.4    Rennie, D.5    Stroup, D.F.6
  • 5
    • 80052307183 scopus 로고    scopus 로고
    • Cochrane handbook for systematic reviews of interventions
    • Version 5.0.2 (updated Sept ). In, Higgins JPT, Green S (eds.).
    • Cochrane handbook for systematic reviews of interventions. Version 5.0.2 (updated Sept 2009). In The Cochrane collaboration group, Higgins JPT, Green S (eds.).
    • (2009) The Cochrane collaboration group
  • 6
    • 80053248206 scopus 로고    scopus 로고
    • Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews. Version 1.0 [Draft posted Oct. ]. Rockville, MD. Available at: .
    • Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews. Version 1.0 [Draft posted Oct. 2007]. Rockville, MD. Available at: .
    • (2007)
  • 8
    • 2942554869 scopus 로고    scopus 로고
    • Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration
    • Jun
    • Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy Jun 2004; 24(6): 743-749.
    • (2004) Pharmacotherapy , vol.24 , Issue.6 , pp. 743-749
    • Hartnell, N.R.1    Wilson, J.P.2
  • 9
    • 0141557914 scopus 로고    scopus 로고
    • Adverse event reporting with selective serotonin-reuptake inhibitors
    • Oct
    • Hartnell NR, Wilson JP, Patel NC, Crismon ML. Adverse event reporting with selective serotonin-reuptake inhibitors. Ann Pharmacother Oct 2003; 37(10): 1387-1391.
    • (2003) Ann Pharmacother , vol.37 , Issue.10 , pp. 1387-1391
    • Hartnell, N.R.1    Wilson, J.P.2    Patel, N.C.3    Crismon, M.L.4
  • 10
    • 40949139727 scopus 로고    scopus 로고
    • Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis
    • Mar
    • McAdams M, Staffa J, Dal Pan G. Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis. Pharmacoepidemiol Drug Saf Mar 2008; 17(3): 229-239.
    • (2008) Pharmacoepidemiol Drug Saf , vol.17 , Issue.3 , pp. 229-239
    • McAdams, M.1    Staffa, J.2    Dal Pan, G.3
  • 11
    • 0025953289 scopus 로고
    • Blind assignment of exposure does not always prevent differential misclassification
    • Aug 15
    • Wacholder S, Dosemeci M, Lubin JH. Blind assignment of exposure does not always prevent differential misclassification. Am J Epidemiol Aug 15 1991; 134(4): 433-437.
    • (1991) Am J Epidemiol , vol.134 , Issue.4 , pp. 433-437
    • Wacholder, S.1    Dosemeci, M.2    Lubin, J.H.3
  • 12
    • 41849101502 scopus 로고    scopus 로고
    • How far from non-differential does exposure or disease misclassification have to be to bias measures of association away from the null?
    • Apr
    • Jurek AM, Greenland S, Maldonado G. How far from non-differential does exposure or disease misclassification have to be to bias measures of association away from the null? Int J Epidemiol Apr 2008; 37(2): 382-385.
    • (2008) Int J Epidemiol , vol.37 , Issue.2 , pp. 382-385
    • Jurek, A.M.1    Greenland, S.2    Maldonado, G.3
  • 13
    • 0033966945 scopus 로고    scopus 로고
    • Prevention of thromboembolism in atrial fibrillation. A meta-analysis of trials of anticoagulants and antiplatelet drugs
    • Jan
    • Segal JB, McNamara RL, Miller MR, et al. Prevention of thromboembolism in atrial fibrillation. A meta-analysis of trials of anticoagulants and antiplatelet drugs. J Gen Intern Med Jan 2000; 15(1): 56-67.
    • (2000) J Gen Intern Med , vol.15 , Issue.1 , pp. 56-67
    • Segal, J.B.1    McNamara, R.L.2    Miller, M.R.3
  • 14
    • 0033527355 scopus 로고    scopus 로고
    • Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis
    • Oct 5
    • Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Inter Med Oct 5 1999; 131(7): 492-501.
    • (1999) Ann Inter Med , vol.131 , Issue.7 , pp. 492-501
    • Hart, R.G.1    Benavente, O.2    McBride, R.3    Pearce, L.A.4
  • 15
    • 0037145826 scopus 로고    scopus 로고
    • Oral anticoagulants vs aspirin in nonvalvular atrial fibrillation: an individual patient meta-analysis
    • Nov 20
    • van Walraven C, Hart RG, Singer DE, et al. Oral anticoagulants vs aspirin in nonvalvular atrial fibrillation: an individual patient meta-analysis. JAMA Nov 20 2002; 288(19): 2441-2448.
    • (2002) JAMA , vol.288 , Issue.19 , pp. 2441-2448
    • van Walraven, C.1    Hart, R.G.2    Singer, D.E.3
  • 16
    • 0035934070 scopus 로고    scopus 로고
    • Risk of cardiovascular events associated with selective COX-2 inhibitors
    • Aug 22-29
    • Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA Aug 22-29 2001; 286(8): 954-959.
    • (2001) JAMA , vol.286 , Issue.8 , pp. 954-959
    • Mukherjee, D.1    Nissen, S.E.2    Topol, E.J.3
  • 17
    • 0037081649 scopus 로고    scopus 로고
    • Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone)
    • Jan 15
    • Reicin AS, Shapiro D, Sperling RS, Barr E, Yu Q. Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone). Am J Cardiol Jan 15 2002; 89(2): 204-209.
    • (2002) Am J Cardiol , vol.89 , Issue.2 , pp. 204-209
    • Reicin, A.S.1    Shapiro, D.2    Sperling, R.S.3    Barr, E.4    Yu, Q.5
  • 18
    • 17944380212 scopus 로고    scopus 로고
    • Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study
    • Jul 17
    • Mahaffey KW, Harrington RA, Akkerhuis M, et al. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study. Curr Control Trials Cardiovasc Med Jul 17 2001; 2(4): 187-194.
    • (2001) Curr Control Trials Cardiovasc Med , vol.2 , Issue.4 , pp. 187-194
    • Mahaffey, K.W.1    Harrington, R.A.2    Akkerhuis, M.3
  • 19
    • 80053232767 scopus 로고    scopus 로고
    • Food and Drug Administration UDoHaHS. Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs improving human subject protection. .
    • Food and Drug Administration UDoHaHS. Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs improving human subject protection. 2009.
    • (2009)
  • 20
    • 66749112344 scopus 로고    scopus 로고
    • Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention
    • Ethgen M, Boutron I, Steg PG, Roy C, Ravaud P. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Trials 2009; 10: 29.
    • (2009) Trials , vol.10 , pp. 29
    • Ethgen, M.1    Boutron, I.2    Steg, P.G.3    Roy, C.4    Ravaud, P.5
  • 21
    • 33845876333 scopus 로고    scopus 로고
    • Risks associated with statin therapy: a systematic overview of randomized clinical trials
    • Dec 19
    • Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation Dec 19 2006; 114(25): 2788-2797.
    • (2006) Circulation , vol.114 , Issue.25 , pp. 2788-2797
    • Kashani, A.1    Phillips, C.O.2    Foody, J.M.3
  • 22
    • 42749084466 scopus 로고    scopus 로고
    • Reporting of adverse events in systematic reviews can be improved: survey results
    • Jun
    • Hopewell S, Wolfenden L, Clarke M. Reporting of adverse events in systematic reviews can be improved: survey results. J Clin Epidemiol Jun 2008; 61(6): 597-602.
    • (2008) J Clin Epidemiol , vol.61 , Issue.6 , pp. 597-602
    • Hopewell, S.1    Wolfenden, L.2    Clarke, M.3
  • 23
    • 2342661718 scopus 로고    scopus 로고
    • What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data
    • May 15
    • Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med May 15 2004; 23(9): 1351-1375.
    • (2004) Stat Med , vol.23 , Issue.9 , pp. 1351-1375
    • Sweeting, M.J.1    Sutton, A.J.2    Lambert, P.C.3
  • 24
    • 61449209942 scopus 로고    scopus 로고
    • Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 x 2 tables with all available data but without artificial continuity correction
    • Apr
    • Tian L, Cai T, Pfeffer MA, Piankov N, Cremieux PY, Wei LJ. Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 x 2 tables with all available data but without artificial continuity correction. Biostatistics (Oxford, England) Apr 2009; 10(2): 275-281.
    • (2009) Biostatistics (Oxford, England) , vol.10 , Issue.2 , pp. 275-281
    • Tian, L.1    Cai, T.2    Pfeffer, M.A.3    Piankov, N.4    Cremieux, P.Y.5    Wei, L.J.6
  • 25
    • 33846260745 scopus 로고    scopus 로고
    • Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events
    • Jan 15
    • Bradburn MJ, Deeks JJ, Berlin JA, Russell Localio A. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Stat Med Jan 15 2007; 26(1): 53-77.
    • (2007) Stat Med , vol.26 , Issue.1 , pp. 53-77
    • Bradburn, M.J.1    Deeks, J.J.2    Berlin, J.A.3    Russell Localio, A.4
  • 26
    • 0030716411 scopus 로고    scopus 로고
    • Association of upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs with continued exposure: cohort study
    • Nov 22
    • MacDonald TM, Morant SV, Robinson GC, et al. Association of upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs with continued exposure: cohort study. BMJ Clinical Research Ed Nov 22 1997; 315(7119): 1333-1337.
    • (1997) BMJ Clinical Research Ed , vol.315 , pp. 1333-1337
    • MacDonald, T.M.1    Morant, S.V.2    Robinson, G.C.3
  • 27
    • 71049122764 scopus 로고    scopus 로고
    • Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team
    • Crowe BJ, Xia HA, Berlin JA, et al. Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team. Clinical Trials 2009; 6(5):430-440.
    • (2009) Clinical Trials , vol.6 , Issue.5 , pp. 430-440
    • Crowe, B.J.1    Xia, H.A.2    Berlin, J.A.3
  • 28
    • 72249116214 scopus 로고    scopus 로고
    • Guidance for Industry: Diabetes mellitus - Evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes
    • Food and Drug Administration. Silver Spring, MD
    • Food and Drug Administration. Guidance for Industry: Diabetes mellitus - Evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Silver Spring, MD, 2008.
    • (2008)
  • 29
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: an extension of the CONSORT statement
    • Nov 16
    • Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Inter Med Nov 16 2004; 141(10): 781-788.
    • (2004) Ann Inter Med , Issue.10 , pp. 781-788
    • Ioannidis, J.P.1    Evans, S.J.2    Gotzsche, P.C.3
  • 30
    • 69149107727 scopus 로고    scopus 로고
    • The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration
    • Liberati A, Altman D, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. Ann Inter Med 2009; 151(4): W1-W29.
    • (2009) Ann Inter Med , vol.151 , Issue.4
    • Liberati, A.1    Altman, D.2    Tetzlaff, J.3
  • 31
    • 34547546947 scopus 로고    scopus 로고
    • A quantitative approach to benefit-risk assessment of medicines--part 1: the development of a new model using multi-criteria decision analysis; part 2: the practical application of a new model
    • Jul
    • Mussen F, Salek S, Walker S. A quantitative approach to benefit-risk assessment of medicines--part 1: the development of a new model using multi-criteria decision analysis; part 2: the practical application of a new model. Pharmacoepidemiol Drug Saf Jul 2007; 16(Suppl 1): S42-S46.
    • (2007) Pharmacoepidemiol Drug Saf , vol.16 , Issue.SUPPL. 1
    • Mussen, F.1    Salek, S.2    Walker, S.3
  • 32
    • 80053236591 scopus 로고    scopus 로고
    • Forum on Drug Discovery D, and Translation, Board on Health Sciences Policy. Institute of Medicine of the National Academies: Washington, DC
    • Forum on Drug Discovery D, and Translation, Board on Health Sciences Policy. Understanding the Benefits and Risks of Pharmaceuticals. Workshop Summary. Institute of Medicine of the National Academies: Washington, DC, 2007.
    • (2007) Understanding the Benefits and Risks of Pharmaceuticals. Workshop Summary
  • 33
    • 59549098910 scopus 로고    scopus 로고
    • A multiattribute model for evaluating the benefit-risk profiles of treatment alternatives
    • Jan-Feb
    • Felli JC, Noel RA, Cavazzoni PA. A multiattribute model for evaluating the benefit-risk profiles of treatment alternatives. Med Decis Making Jan-Feb 2009; 29(1): 104-115.
    • (2009) Med Decis Making , vol.29 , Issue.1 , pp. 104-115
    • Felli, J.C.1    Noel, R.A.2    Cavazzoni, P.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.